NA 901-0048Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03700586902947), received between Aug 15, 2024 and Aug 22, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT WHERE THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE 1.8MM) ARE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION, THIS HAS HAPPENED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INITIALLY IN A CASE RESULTING IN ANOTHER KIT BEING USED AND EXTENDED UNDER ANESTHETIC TIME. SURGERY WAS COMPLETED BY USING CHARLOTTE MUC KIT. INQUIRY (B)(6) - EVENT DATE (B)(6) 2024 SATURDAY ¿ CASE PROCEEDED WITH CHARLOTTE MUC. 4 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031025 ↗
• MalfunctionAug 22, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT WHERE THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE 1.8MM) ARE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION, THIS HAS HAPPENED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INITIALLY IN A CASE RESULTING IN ANOTHER KIT BEING USED AND EXTENDED UNDER ANESTHETIC TIME. SURGERY WAS COMPLETED BY USING CHARLOTTE MUC KIT. INQUIRY PI (B)(4) - EVENT DATE 07/20/2024 SATURDAY ¿ CASE PROCEEDED WITH (B)(6). 4 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20030844 ↗
• MalfunctionAug 21, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT, THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE, 1.8MM) WERE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION. THIS ISSUE HAS OCCURRED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INTRA-OPERATIVELY, CAUSING THE SURGERY TO BE FULLY CANCELED WHILE THE PATIENT WAS ALREADY PREPARED IN THE ROOM. INQUIRY PI (B)(6) ¿ EVENT DATE (B)(6) 2024 TUESDAY. CASE CANCELLED. 2 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018243 ↗
• InjuryAug 21, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT, THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE, 1.8MM) WERE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION. THIS ISSUE HAS OCCURRED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INTRA-OPERATIVELY, CAUSING THE SURGERY TO BE FULLY CANCELED WHILE THE PATIENT WAS ALREADY PREPARED IN THE ROOM. INQUIRY (B)(4) ¿ EVENT DATE 07/23/2024 TUESDAY. CASE CANCELLED. 2 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20011061 ↗
• MalfunctionAug 20, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT, THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE, 1.8MM) WERE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION. THIS ISSUE HAS OCCURRED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INTRA-OPERATIVELY, CAUSING THE SURGERY TO BE FULLY CANCELED WHILE THE PATIENT WAS ALREADY PREPARED IN THE ROOM. INQUIRY (B)(4) - EVENT DATE 07/23/2024. CASE CANCELED. 3 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005349 ↗
• InjuryAug 20, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT, THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE, 1.8MM) WERE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION. THIS ISSUE HAS OCCURRED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INTRA-OPERATIVELY, CAUSING THE SURGERY TO BE FULLY CANCELED WHILE THE PATIENT WAS ALREADY PREPARED IN THE ROOM. INQUIRY PI 3703869 - EVENT DATE 07/23/2024. CASE CANCELED. 3 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004105 ↗
• MalfunctionAug 15, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT WHERE THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE 1.8MM) ARE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION, THIS HAS HAPPENED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INITIALLY IN A CASE RESULTING IN ANOTHER KIT BEING USED AND EXTENDED UNDER ANESTHETIC TIME. SURGERY WAS COMPLETED BY USING COMPETITOR KIT. INQUIRY PI (B)(6) - EVENT DATE (B)(6) 2024 FRIDAY. CASE COMPLETED WITH COMPETITOR KIT. 1 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997082 ↗
• MalfunctionAug 15, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT WHERE THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE 1.8MM) ARE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION, THIS HAS HAPPENED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INITIALLY IN A CASE RESULTING IN ANOTHER KIT BEING USED AND EXTENDED UNDER ANESTHETIC TIME. SURGERY WAS COMPLETED BY USING COMPETITOR KIT. INQUIRY (B)(4) EVENT DATE 07/19/2024 FRIDAY. CASE COMPLETED WITH COMPETITOR KIT. 1 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997081 ↗
• MalfunctionAug 15, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE COMPANY REP: DURING MULTIPLE CASES USING THE 6.5 AUTOFIX LOAN KIT WHERE THE K-WIRES PROVIDED (OR ONES OF THE SAME SIZE 1.8MM) ARE NOT FITTING THROUGH THE AUTOFIX INSTRUMENTATION, THIS HAS HAPPENED IN MULTIPLE INSTRUMENT SETS. THE ISSUE WAS DISCOVERED INITIALLY IN A CASE RESULTING IN ANOTHER KIT BEING USED AND EXTENDED UNDER ANESTHETIC TIME. SURGERY WAS COMPLETED BY USING COMPETITOR KIT. INQUIRY PI 3697784 - EVENT DATE(B)(6) 2024 FRIDAY. CASE COMPLETED WITH COMPETITOR KIT. 1 OUT OF 4.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997078 ↗